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临床试验/NCT04342403
NCT04342403Unknown不适用

Clinical Studies Network Research Trial: Development of an On-Line Sarcoidosis Assessment Platform (OSAP) to Validate Sarcoidosis Phenotypes and Monitor Disease Burden Longitudinally

University of Cincinnati3 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
350
试验地点
3
主要终点
KSQ

研究概览

简要总结

Evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of sarcoidosis by established criteria.
  • Patient has completed pulmonary function tests (spirometry) as per standard of care at the enrollment visit.
  • Ability to understand and read English at least at a 7th grade level.
  • Have access to a computer, iPad, smart phone, or another electronic device that will support the on-line sarcoidosis assessment platform.
  • The subject is willing to wear a daily activity and sleep tracker wristband (Fitbit ™ wristband) for 6 months.

排除标准

  • Life expectancy of < 1 year.

结局指标

主要结局

KSQ

时间窗: 6 months

Change in KSQ

次要结局

  • Forced Vital Capacity (FVC)(6 months)
  • SAT(6 Months)
  • Visual Analog Scale (VAS)(6 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert P Baughman

Professor

University of Cincinnati

研究点 (3)

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